American Patent System

• United States Patent and Trademark Office

• The Leahy-Smith America Invents Act (AIA) 2011

• CFR Title 35 of the US code governs patents law

• USPTO has its own court system, the Patent Trial

and Appeal Board

• The patentee must enforce the patent

BITS Pilani, Pilani Campus

Types of patents

• Utility
• also known as “patents for invention”
• new and useful process, machine, article of manufacture,
or composition of matter, or any new and useful
improvement thereof
• Design
• New, original, and ornamental design for an article of
manufacture
• Plant
• Asexual reproduction any distinct and new variety of
plant

BITS Pilani, Pilani Campus

Patentability

• Sections 100 to 105 describes patentability of

inventions

• a new, nonobvious and useful process, machine,

article of manufacture, or composition of matter

• Some inventions can not be patented

• NUNS test

BITS Pilani, Pilani Campus

Conditions of patentability

• Utility: condition that the subject matter has a useful purpose

and also includes operativeness, that is, a machine which
will not operate to perform the intended purpose would not
be called useful
• Novelty: A claim is anticipated only if each and every
element as set forth in the claim is found, either expressly or
inherently described, in a single prior art reference
• Non-obviousness: if the differences between the claimed
invention and the prior art are such that the claimed
invention as a whole would have not been obvious before
the effective filing date of the claimed invention to a person
having ordinary skill in the art to which the claimed invention
pertains
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Types of patent applications

• Provisional

• Non-provisional

• Divisional

• Continuation

• Continuation-in-part

• Reissue

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Prior art and patent search

• “Prior art” is a legal term that essentially means an

invention that already exists.

• PAIR (Public Patent Application Information

Retrieval)

• Other databases

• Non-patent literature

BITS Pilani, Pilani Campus

Patent prosecution

BITS Pilani, Pilani Campus

Patent prosecution

BITS Pilani, Pilani Campus

Patent
prosecution

BITS Pilani, Pilani Campus

Patent term adjustment (PTA)

• PTA = 14-4-4-4-4 Rule delay + 3-Year Rule delay +

PTAB Rule delay - Applicant Delay - Overlapping
delay

Terminal disclosure
• process by which a patent's term is shortened
because it duplicates the claims of another patent
which expires sooner.

BITS Pilani, Pilani Campus

Patent term extension

• The Drug Price Competition and Patent Term

Restoration Act, informally known as the Hatch-
Waxman Act 1984

• Need for the act

• Objectives

• Provisions

• Orange book
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ANDA certifications

(I) Paragraph I: that there are no patents listed in the

Orange Book for the drug;
(II) Paragraph II: that the relevant patents have
expired;
(III) Paragraph III: that the generic manufacturer will
not seek approval of the ANDA until after expiration
of the relevant patent; or
(IV) Paragraph IV: that such a patent is invalid or will
not be infringed by the manufacture, use, or sale of
the new generic drug for which the ANDA is
submitted.
BITS Pilani, Pilani Campus
Para IV challenge

BITS Pilani, Pilani Campus